Category:

Journal of Regulatory Compliance

Safeguarding Your Face: Regulating Facial Recognition Technologies

The use of facial recognition technology in the commercial context generates numerous consumer privacy concerns. As technology becomes increasingly present in many aspects of our life, regulations on states and federal level are struggling to catch up. Currently, only three states (Illinois, Washington, and Texas) implemented biometric privacy laws, and only Illinois grants individuals with a private right of action.

HIPAA And The Growth Of Technology

Earlier in 2019, a lawsuit was filed against University of Chicago Medicine, University of Chicago Medical Center, and Google. The suit claims that patient information was shared with google as part of a study aimed to advance the use of Artificial Intelligence, however, patient authorization was not obtained and the data used was not properly de-identified. In 2017, University of Chicago (UChicago) Medicine started sending patient data to Google as part of a project to look to see if historical health record data could be used to predict future medical events.

Recent Movements in Biometric Data Privacy

In 2008, the Illinois legislature introduced and passed the Biometric Information Privacy Act (BIPA), which became the first law of its kind in the US. BIPA was passed to protect individuals against the unlawful collection and storing of biometric information. While many states have enacted similar laws, BIPA remains the most stringent among its contemporaries.

FDA Issues Warnings Regarding E-Cigarettes

On Wednesday, September 11, 2019, the Trump Administration issued a statement regarding the recent outbreak of illnesses and deaths related to the use of electronic cigarettes (“e-cigarettes”). Soon after, the Food and Drug Administration (“FDA”) quickly followed suit. The Trump Administration’s statement comes after reports of 380 cases of lung illness associated with the use of e-cigarettes in 36 states, in addition to 7 deaths. Both political parties have pressed for flavor bans, age restrictions, and other restrictions on the sale of vaping products. They have urged the FDA to move quickly and decisively to investigate and regulate e-cigarettes. E-cigarettes have been touted by manufacturers as a way to wean people from traditional cigarettes but have recently led to an “epidemic” of youth vaping of nicotine. E-cigarettes are popular among teens due to their availability, advertisements, e-liquid flavors, and the belief that they are safer than cigarettes. The long-term risks of vaping are currently unknown, but a growing numbers of studies show that e-cigarette vapor has severe health risks, including damaging lung tissue and blood vessels.

The FDCA and Cosmetics Enforcement: Better Late than Never

In March 2019, the FDA issued a statement explaining that asbestos was found in certain cosmetic products sold at retail stores Claire’s and Justice. The Food, Drug, and Cosmetics Act (FDCA) has always granted the FDA similar authority to monitor cosmetic products for adulteration or misbranding as it does food. However, litigation in this area was notably silent. The FDA’s change in position on its authority is long overdue.

How Will Recreational Marijuana Impact Illinois? 

During Governor-elect J.B. Pritzker’s election campaign, he heavily advocated for Illinois to be more accommodating to recreational marijuana usage. In Illinois, medical marijuana has already been legalized, and new bills are being introduced to make it more accessible. If recreational marijuana is legalized, Illinois will join ten states, and the District of Colombia, in its authorization.

Regulating the Un-Explainable: The Difficulties in Regulating Artificial Intelligence

From Siri to Alexa, to deep learning algorithms, artificial intelligence (AI) has now become commonplace in most peoples’ lives.  In a business context, AI has become an indispensable tool for businesses to utilize in accomplishing their goals. Due to the complexity of the algorithms required to make quick and complex decisions, a “black box problem” has emerged for those who utilize these increasingly more elaborate forms of AI. The “black box” simply refers to the level of opacity that shrouds the AI decision-making process. While no current regulation explicitly bans or restricts the use of AI in decision making processes, many tech experts argue that the black box of AI needs to be opened in order to deconstruct not only the technically intricate decision-making capabilities of AI, but the possible compliance-related problems this type of technology may cause.

The Future of Online Prescribing

Telehealth allows for the delivery and facilitation of medical services through technology. It is rapidly evolving as the tech industry grows. Ten years after the passage of the Ryan Haight Act, the Drug Enforcement Agency (DEA) has still not taken any action to assist physicians in their usage of telehealth. Recently, Congress finally stepped in and passed a bill that requires the DEA to take action within the next year. But, the question still remains whether the DEA will finally act, or continue their history of avoidance?

Proposed Changes to the Clinical Laboratory Improvement Amendments of 1988

The Department of Health and Human Services Center for Medicare and Medicaid Services have proposed a ruleto update the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  The new rule seeks to address current analytes, substances or constituents for which the laboratory conducts testing, and newer technologies.  The rule would further make technical changes to the PT referral regulations to be more closely aligned with the CLIA statute.

The Ugly Side of Beauty: How Under-Regulation of Cosmetics Harmed Consumers for Decades   

It is no secret that the beauty industry in America is frighteningly under-regulated. Cosmetics companies and beauty brands have managed to escape meaningful regulatory oversight for roughly a century and are largely left to self-regulate. In 2017, the global cosmetic products market was valued at $532 billion and is expected to reach a market value of $806 billion by 2023, registering a compound annual growth rate of 7.14%. Despite the colossal financial growth, regulatory shortcomings leave much to be desired by consumers. On the back of numerous harmful side-effects scandals and multi-million dollar class-action settlements, the FDA must grapple with renewed demand for cosmetics regulation as new beauty trends emerge.